For years now Thyroid Eye Disease (TED) has been a struggle to anyone suffering from it, with limited treatment options available on hand & sometimes the need to undergo multiple reconstructive procedures has made it even a bigger burden for a lot of people.
Thyroid Eye Disease (TED), also called Graves’ eye disease, is a rare autoimmune condition that causes inflammation in the tissues around the eyes. This can lead to symptoms like bulging eyes, swelling, redness, pain, double vision, and eyelid retraction. In severe cases, it may result in vision loss or changes in facial appearance.
Recently EMA has granted marketing authorization in the European union for the use of Tepezza (teprotumumab) for treatment of adults struggling from moderate to severe thyroid eye disease.
The CHMP’s recent clinical trials involving three randomized placebo-controlled trials involving 225 patients with active Thyroid Eye Disease (TED), and one trial with 62 patients who had chronic TED. After 24 weeks of treatment, patients receiving Tepezza showed a significant improvement in eye bulging (proptosis), with a reduction of 2 to 2.3 mm, along with lower scores on the Clinical Activity Score (CAS), which measures inflammation and symptoms of TED. In patients with chronic TED, the improvement in eye bulging was smaller, at about 1.5 mm.
Tepezza is a type of monoclonal antibody that works by blocking the autoimmune activation of orbital fibroblasts, which in turn prevents further development & worsening of TED.
Tepezza's most common side effects include muscle spasms, diarrhea, hair loss, high blood sugar, fatigue, nausea, and headaches. Clinical trials and post-marketing data indicate a risk of severe, potentially permanent hearing loss. Pre-clinical studies suggest potential risks to fetal development. Risk minimization strategies will be put in place to address these concerns.
The CHMP's opinion is a step towards Tepezza's approval. It will now be sent to the European Commission for an EU-wide marketing authorization. Once approved, pricing and reimbursement decisions will be made by each Member State based on the medicine's role in their healthcare system.
Learn more: First treatment against severe thyroid eye disease | European Medicines Agency (EMA)
